FDA recall, , Moderate risk
Chiesi Curosurf Intratracheal Suspension
Curosurf (poractant alfa) lacks assurance of sterility.
Summary by Recall Canary from the FDA notice
What happened
Chiesi USA, Inc., of Cary, North Carolina, recalled Curosurf (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, because of lack of assurance of sterility. The company began the recall on March 17, 2026, and the FDA classified it on March 20, 2026, adding it to the Enforcement Report on March 27, 2026. The product was distributed nationwide within the United States.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial
- NDC
- 10122-510-03
- Lot code
- 1213748
- 1215076
- 1215077
Recall details
- Company began the recall
- Sold in
Nationwide within the United States
- Company
- Chiesi USA, Inc.Cary, North Carolina
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98593
- Recall number
- D-0402-2026
- Quantity recalled
- 7,235 vials
All recalls from Chiesi USA, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Classified by FDA
Added to FDA's Enforcement Report
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
